VM-2500-MG User Manual Ver EN 1.3 July 2012

Declaration of Conformity

0086

This product meets the requirements of the 93/42/EEC guidelines for medical products.

Liability Viamed Ltd. shall in no event be liable for any direct, indirect, special or consequential damages including without limitation damages for loss of business profits, loss of income, business interruption, loss of business information, loss of use or other related exposures, however caused, arising from the faulty or incorrect use of the product. Viamed Ltd. guarantees that the product delivered has been thoroughly tested to ensure that it meets its published specifications.

Warranty Viamed Ltd. warrants the products manufactured or distributed by them to be free from faulty materials and workmanship for a period of 24 months from date of original shipment to first end user except for disposable products or products which have a stated guarantee longer or shorter than 24 months. Viamed Ltd. will perform warranty service at its factory. The obligations for Viamed Ltd. under this guarantee shall be limited to repair, or at Viamed Ltd.´s discretion, replacement of necessary parts or assemblies and shall not include shipping costs or other incidental damages. Claims for damages during shipment must be filed promptly with the transportation company. All correspondence concerning the products must specify both the name of the product and its serial number as written on the label on the product. Use of the equipment for other than its intended use, or if it has been repaired by anyone except Viamed Ltd. or a Viamed Ltd. authorized service centre, or altered or modified or used without following the instructions in the user manual, will void this guarantee.

Patents PHASEIN AB holds the following patents regarding products described in this manual: SE519766; SE519779; SE523461; SE524086. Other patents pending

Trademarks PHASEIN IRMA™ and PHASEIN XTP™ are trademarks of PHASEIN AB.

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Table of Contents 1

Introduction ... 6 1.1 1.2 1.3 1.4 1.5 1.6

2

Intended Use ... 6 Warnings ... 6 Cautions ... 10 Symbol Description ... 12 Terms and Definitions ... 13 User Requirements ... 14

Theory of operation ... 15 2.1 Multigas measurement ... 15 2.1.1 Principle ... 15 2.1.2 Method ... 16 2.1.3 Capnogram ... 16 2.1.4 MAC calculation ... 16 2.2 SpO2 measurement ... 18

3

Product overview... 18 3.1 Mainstream multigas monitor and Pulse oximeter – VM-2500-MG ... 18 3.2 Device components ... 19 3.2.1 IRMA™ AX+ analyzer ... 19 3.2.2 IRMA™ airway adapter... 19 3.3 SpO2 Sensors ... 20

4

Exterior View, Controls and Connectors ... 21

5

Preparation for Use ... 22 5.1 Selecting Power Supply... 22 5.1.1 Power Supply ... 22 5.1.2 Li-Poly Battery or AA Alkaline Batteries... 23 5.2 Connecting Sensors to the VM-2500-MG... 24 5.2.1 IRMA™ AX+ Analyzer... 24 5.2.2 SpO2 Sensor ... 24 5.3 Visual Check ... 24 5.4 Switching on the Device... 25 5.5 Connecting the Sensors to the Patient ... 25 5.5.1 IRMA™ AX+ Analyzer... 25 5.5.2 SpO2 Sensor ... 27 5.6 Commencing Monitoring ... 28 5.7 Switching off the Device ... 28

6

Display Modes and Displayed Data ... 29 6.1 6.2 6.3

7

Toggling Between Display Modes ... 29 Symbols and Indicators ... 31 Pulse Tone ... 32

Alarms ... 33 7.1 7.2 7.3

Alarm Priority and Appearance ... 33 Audible Alarm Volume ... 33 Default Alarm Limits ... 33

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7.4 7.5 7.6 7.7 8

Limit Alarms ... 34 Alarm Messages ... 35 ICU Alarm Mode... 36 Resetting of Alarm Signals... 36

Menu Structure ... 37 8.1 Main Menu ... 37 8.1.1 Submenu: Alarm Settings ... 38 8.1.2 Submenu: Data Management ... 40 8.1.2.1 Recording Data ... 40 8.1.2.2 Data Management ... 40 8.1.3 Submenu: Setup ... 42 8.1.3.1 General Information ... 42 8.1.3.2 Parameters ... 43 8.1.4 Submenu: Patient ID ... 48 8.1.5 Start Up Settings ... 48 8.2 Other ... 49 8.2.1 Volume Control Shortcut ... 49 8.2.2 Brightness Control Shortcut ... 49 8.2.3 Power-Save Mode ... 49

9

Adverse effects on performance... 49 9.1 9.2

10

Troubleshooting guide ... 50 10.1 10.2 10.3 10.4

11

Multigas measurements ... 49 SpO2 Measurement ... 50 Error Message – Cause - Corrective Action ... 50 Failure – Cause - Corrective Action ... 52 IRMA™ AX+ LED Status ... 53 Problems with EMI (Electromagnetic Interference)... 53

Maintenance ... 54 11.1 11.2 11.3 11.4

Maintenance ... 54 Cleaning ... 54 Testing ... 55 Zeroing the multigas monitor ... 55

12

VM-2500-MG PC-Software ... 56

13

Technical Specifications ... 57

14

Component Lists and Ordering ... 62 14.1 14.2 14.3 14.4 14.5 14.6

Packing List ... 62 Order Number ... 62 Disposables ... 62 SpO2 Accessories ... 63 Other Accessories ... 63 Replacement Parts ... 63

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1

Introduction

1.1 Intended Use The VM-2500-MG Multigas / SpO2 Monitor is intended to provide continuous monitoring of endtidal (et) CO2-, N2O- and anaesthetic agent concentrations, inspired (Fi) CO2-, N2O- and anaesthetic agent concentrations, functional arterial oxygen saturation (SpO2), respiration rate (RR), pulse rate (PR) and MAC value. The multigas analyzer is intended to be connected to a patients breathing circuit for monitoring of inspired/expired gasses during anaesthesia, recovery and respiratory care. It may be used in the operating suit, intensive care unit, patient room and emergency settings for adults, paediatric and infant patients. The VM-2500-MG Multigas/SpO2 Monitor is not intended to be used as the only means of monitoring a patient. It shall always be used in combination with other vital sign monitoring devices and/or professional human judgments of a patient’s condition. The VM-2500-MG is intended to be used by trained and authorized health care professionals only. 1.2 Warnings Adhere to the following warnings for safe operation of the VM-2500-MG Multigas / SpO2 Monitor. For VM-2500-MG in general: Warning: The monitor is to be operated only by trained personnel and is for attended monitoring only. Warning: Do not make any clinical judgments based solely on the VM-2500-MG. The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. The interpretation of the measurement values should be done only by trained health care professionals. Warning: The monitor should only be used for the purpose and in the manner described in this manual. Warning: Explosion hazard. Do not use the monitor in the presence of flammable anaesthetic mixtures with air, oxygen, or nitrous oxide. Warning: Routinely monitor the patient to make sure that the VM-2500-MG is functioning correctly and that the SpO2 sensor and the IRMA™ AX+ analyzer are correctly placed. Warning: Do not place the monitor in any position that might cause it to fall on to the patient.

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Warning: Certain environmental and physiological conditions, medical procedures, sensor application errors and external agents may interfere with the monitor‘s ability to detect and display accurate measurements. (Chapter 9 provides information on possible interferences) Warning: For the SpO2 measurement, the monitor uses red and infrared light with specific fixed wavelengths. Consider that these wavelengths might influence diagnostic parameters of other optical applications. The specifications of the wavelengths used are listed in the ‘Instructions for Use’ of the specific sensor. Warning: The monitor detects respiratory effort via changes in CO2 concentration of exhaled air; therefore, the CO2 measurement can be used to detect apnoea. The device however is unable to discriminate between a patient not breathing and a sensor that is disconnected from the patient circuit. Always monitor and set alarms for SpO2 when using the VM-2500-MG to monitor respiratory function. Warning: If you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means; then make sure the monitor is functioning correctly. Warning: The use of accessories, sensors, and cables other than those specified may result in increased electromagnetic emission and/or create invalid readings of the monitor. Warning: In high ambient light conditions it is required to shield the SpO2 sensor application site with opaque material. Too much ambient light may result in inaccurate measurements. Warning: Check all alarm settings and auditory alarm before use of the monitor. Warning: Do not silence the audible alarm function, or decrease the audible alarm volume if patient safety could be compromised. Warning: No modifications of the monitor are allowed without authorization of the manufacturer. Warning: Measurements can be affected by mobile and RF communications equipment. Make sure that the monitor is used in the electromagnetic environment specified in this manual. VM-2500-MG User Manual | Viamed Ltd. 2012

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Warning: Disconnect the monitor and probes from the patient during computed tomography (CT). Warning: Disconnect the monitor and probes from the patient during magnetic resonance imaging (MRI) scanning. An induced current could potentially cause burns.

Additional warnings regarding the power supply system: To prevent the possibility of the Li-Poly battery CT-2500 from leaking, heating or explosion, observe the following precautions. Warning: Do not immerse the battery in water or seawater. Store it in a cool and dry environment if not used. Warning: Do not discard, store or use the battery near a heat source (e.g. a fire or heater). Warning: Only charge the Li-Poly battery CT-2500 while inserted in the VM-2500-MG monitor using the provided power supply FW 7660M/06. Warning: Do not connect the positive and negative terminal with metal objects such as wire and do not transport or store the battery together with metal objects such as necklaces or hairpins as this may short-circuit the battery. Warning: Do not strike, throw or trample the battery or pierce it with a nail or other sharp object. Warning: Only use the Li-Poly battery Model No. CT-2500 provided with the monitor. Contact the manufacturer for replacements. Warning: Only use the power supply Model No. FW 7660M/06 provided with the monitor. The use of a power supply other than this may result in hazardous situation and effect patient’s safety. Warning: Do not use rechargeable AA sized batteries instead of alkaline AA sized batteries to operate the device, as this may affect the function of the device.

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Additional warnings regarding the IRMA™ AX+ Analyzer:

Warning: Disposable IRMA™ airway adapters shall not be reused. Reuse of the single use adapter can cause cross infection. Used airway adapters shall be disposed of in accordance with local regulations for medical waste.

Warning: Do not use the IRMA™ airway adapter (adult/paediatric) with infants as the adapter adds 6ml dead space to the patient circuit. Warning: Do not use the IRMA™ airway adapter (infant) with adults or paediatric as this may cause excessive flow resistance. Warning: Do not place the IRMA™ airway adapter between the endotracheal tube and an elbow as this may allow patient secretions to block the adapter windows and result in incorrect operation.

Warning: To keep secretions and moisture from pooling on the windows, always position the IRMA™ AX+ analyzer in a vertical position.

Warning: Do not use the IRMA™ AX+ analyzer with metered dose inhalers or nebulised medication as this may affect the light transmission of the airway adapter windows. Warning: A successful zeroing requires the presence of ambient air (21% O2 and 0% CO2) in the IRMA™ airway adapter during zeroing. Incorrect zeroing of the IRMA™ AX+ analyzer will result in false gas readings. Warning: Replace the IRMA™ airway adapter if condensation occurs inside the adapter. Warning: The IRMA™ Analyzer is not intended to be in patients contact.

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1.3 Cautions Adhere to the following recommendations to avoid damage or malfunction of the VM-2500-MG Multigas / SpO2 Monitor. For VM-2500-MG in General: Caution: Do not spray, pour, or spill any liquid on the monitor, its accessories, connectors, switches, or openings in the enclosure as this may damage it. Caution: Do not immerse the monitor or its accessories in liquid. Caution: Do not autoclave or steam sterilize the monitor or its accessories. Caution: Refer to the specific ‘Instructions for Use’ of the used SpO2 sensor for correct cleaning and/or sterilization. Caution: Do not apply excessive tension to any of the monitor cables. Caution: Do not operate the monitor outside the specified operating temperature environment. Caution: The monitor requires no routine calibration. A basic maintenance plan conducted by qualified service personnel is recommended. Please refer to the Service Manual for detailed information. Caution: There are no user-serviceable parts inside the VM-2500-MG. The cover should only be removed by qualified service personnel. The warranty does no longer apply, if the cover is opened by unqualified service personnel.

Additional cautions regarding the power supply system: Caution: Do not use or store the Li-Poly battery at very high temperature conditions e.g. strong direct sunlight or in a heated vehicle. Under these conditions the battery can overheat, causing it to burn or its performance will degenerate and its service life will be decreased.

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Caution: Do not use the Li-Poly battery in an electromagnetic environment other than specified in this manual, as this may damage the safety features of the battery and result in unforeseen danger. Caution: If the Li-Poly battery leaks and the electrolyte gets into the eyes, immediately rinse the eyes with clean running water and seek medical assistance to prevent injury of the eyes. Caution: If the Li-Poly battery gives off an odour, generates heat, becomes discoloured or deformed, or in any way appears abnormal during use, recharging or storage, immediately remove it from the device and stop using it. Caution: If the Li-Poly battery terminals are dirty, clean the terminals with a dry cloth before use, otherwise a power failure or charging failure may occur due to poor connection with the device. Caution: Discharged batteries may cause fire; tape the terminals to isolate them. Caution: Remove the batteries if the device is to be stored or not used for a longer period of time. Additional cautions regarding the IRMA™ AX+ Analyzer: Caution: Do not immerse the IRMA™ AX+ analyzer in liquid. Caution: The IRMA™ AX+ analyzer and the IRMA™ airway adapters are non-sterile devices. To avoid damage, do not autoclave these components. Caution: Use only PHASEIN manufactured IRMA™ airway adapters.

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1.4

Symbol Description Accompanied with “Warning: Supplementary text.” within this document. Warnings indicate potential harmful conditions that may lead to injury or death. Accompanied with “Caution: Supplementary text.” within this document. Cautions indicate conditions that may lead to damage to or malfunction of the device. Note:

Denoted as “Note: Supplementary text.” within this document. Notes inform the user to relevant facts and conditions in connection with the device. Consult User Manual for detailed operating information.

Consult accompanying documents for important safety-related information

Manufacturer

Date of manufacture

Type BF applied part

Catalogue number

Serial number

P/N

Part number

Batch code Use by [YYYY-MM-DD] (indicates that the device should not be put into service after the date accompanying the symbol) Temperature limitation

Do not re-use

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Fragile, handle with care Do not dispose in the consumer waste. Electrical and electronic equipment shall be collected and recycled in accordance with (Directive 2002/96/EC) 0000 European Union approval (complies with 93/42/EEC Medical Device Directive) IPXY

1.5

IP Code (International Protection Rating)

Terms and Definitions

BTPS

Body Temperature and Pressure Saturated

VM-2500-MG

Handheld Multigas/SpO2 monitor

CO2

Carbon dioxide

N2O

Nitrous oxide (laughing gas)

DES

Desflurane

ENF

Enflurane

HAL

Halothane

ISO

Isoflurane

SEV

Sevoflurane

et

End-tidal expired gas concentration

Fi

Fraction of inspired gas concentration

MAC

Minimum alveolar concentration

Hb

Deoxygenated haemoglobin

HbO2

Oxygenated haemoglobin

HME

Heat Moisture Exchanger

ICU

Intensive Care Unit

IR

Infrared

IRMA™ AX+

Infrared mainstream multigas analyzer

Li-Poly battery

Lithium-ion polymer rechargeable battery

MDD

Medical Device Directive

MRI

Magnetic Resonance Imaging

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N/A

Not applicable. Data does not apply to the configuration.

PR

Pulse rate

RF

Radio frequency

RH

Relative humidity

Rise time

Time required to achieve an increase from 10% to 90% of final value when step function change in concentration occurs at the sampling site.

RR

Respiration rate

SpO2

Functional arterial oxygen saturation

TBD

To Be Determined. Value or property not yet decided; further investigations may be necessary.

Total system response time

Time from a step function change in gas level at the sampling site to the achievement of 90% of the final gas reading of the capnograph. Total system response time = Delay time + Rise time

USB

Universal Serial Bus

Zeroing

Ambient gas reference measurement used to establish zero concentration level for measured gasses. Zeroing needs to be performed when an offset in gas measurement values is observed, when an unspecified accuracy message is displayed and each time the IRMA™ airway adapter is replaced.

1.6 User Requirements The user(s) of the monitor shall have an in-depth knowledge of gas analyzing and non-invasive monitoring of functional arterial oxygen saturation.

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2

Theory of operation

2.1

Multigas measurement

2.1.1

Principle

The measurement of CO2, N2O and anaesthetic agents (DES, ENF, HAL, ISO, SEV) in gas mixtures with the VM-2500-MG is based on the fact that different gases absorb infrared light at specific wavelengths. The absorption spectra for CO2, N2O and different anaesthetic agents are shown in the figure below.

Figure 1: Gas absorption spectra

The gas analyzer of the VM-2500-MG uses the absorption peak at 4.2µm and 4.5µm for the measurement of CO2 and N2O respectively and five different wavelengths in the 8 – 10 µm range for anaesthetic agent measurement. Two additional wavelengths beside this absorption peak are used as reference. To measure the absorption of light at these wavelengths, a broadband infrared radiation source is used. The light transmitted from the infrared source passes through the gas sample and is then filtered using a set of narrow optical bandpass filters. The individual filters are mounted in a rapidly rotating filter wheel that intersects the light path before the light reaches the infrared detector. The infrared detector detects the portion of the light that is not absorbed by the gas. The amplitude of the detector output is an inverse function of the gas concentration. Thus, at a concentration of zero, the amplitude is at its maximum.

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2.1.2

Method

Determining multiple gas concentration of respiratory gases is performed using the mainstream method (non-dispersive spectroscopy). Here an airway adapter is, for example, inserted between the endotracheal tube and the Y-piece of the breathing circuit. The airway adapter has an optical window over which the infrared mainstream analyzer is positioned. The respiratory multigas measurements are obtained by continuously measuring the infrared light absorption, in the gas flow, through the optical windows. 2.1.3

Capnogram

A capnogram is a graph representing the CO2 concentration in respiratory gasses plotted against time. The capnogram waveform is typically divided into 4 phases (Bhavani-Shankar & Philip, 2000). In the waveform below the inspiration (phase 0) is plotted in blue and the expiration (phase I - III) in red.

Figure 2: Normal capnogram waveform

Phase I: Baseline (FiCO2) Phase II: Positive expiration slope (alveolar gas) Phase III: Alveolar plateau (EtCO2) Phase 0: Inspiration A capnogram provides valuable information regarding the health situation of patients in respiratory distress. 2.1.4

MAC calculation

The MAC (Minimum Alveolar Concentration) is the concentration of an anaesthetic agent that prevents a reaction (e.g. movement) to a painful surgical stimulus (e.g. a standardized skin incision) in 50% of a population of anesthetized patients. The MAC is dependent on body temperature, atmospheric pressure and patient’s age. To be able to compare MAC values the standard 1MAC concentrations of anaesthetic agents and nitrous oxide is used. The 1MAC is based on the assumptions that the patient is 40 years old (except for Desflurane where 25 years are assumed), the body temperature is 37° and the atmospheric pressure is 760 mmHg (1 atm). Uncorrected MAC: The MAC value displayed at the VM-2500-MG is calculated by using the end-tidal (et) gas concentrations of the inhaled anaesthetics (including primary agent AA1, secondary agent AA2 and N2O) and normalizing these to the respective 1MAC according to the following formula:

MAC =

etConc( AA1) etConc( AA2) etConc( N 2 O) + + 1MAC ( AA1) 1MAC ( AA2) 1MAC ( N 2 O)

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The 1MAC values used are according to the EN ISO 21647:2004 standard and listed in the following table: Anaesthetic Halothane 0.77% 1MAC

Enflurane 1.7%

Isoflurane 1.15%

Desflurane 7.3%

Sevoflurane 2.1%

N2O 100%

Note: This MAC value is not corrected for ambient pressure, age, temperature or any other individual factors influencing the effect of volatile anaesthetic agents.

Age corrected MAC: The VM-2500-MG features the possibility of performing a MAC age correction. Activate this mode by setting the “MAC age correction” to “On” within the SETUP MENU. The age corrected MAC value displayed at the VM-2500-MG is calculated according to the following formula. Corrected MAC value of an anaesthetic agent (all except Enflurane): MAC corr _ AA =

etConc( AA) 1MAC ( AA) × 1.32 × 10 −0.00303×age

Note: There is no clinical data available for an age correction of the MAC value of Enflurane. Therefore the MAC is not corrected for Enflurane even if this function is selected.

Corrected MAC value of nitrous oxide:

MACcorr _ N 2O =

etConc( N 2 O) 100 × 1.378 × 10 −0.00347×age

Total Age Corrected MAC value: MAC corr = MAC corr _ AA1 + MAC corr _ AA 2 + MAC corr _ N 2O

This calculation is based on the study performed by Edmond I Eger II which was published in the article Age, minimum alveolar anaesthetic concentration and minimum alveolar anaesthetic concentration-awake (Anesth Analg 2001, 93: 947-53).

Note: This MAC value is not corrected for ambient pressure, temperature or any other individual factors influencing the effect of volatile anaesthetic agents.

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2.2 SpO2 measurement SpO2 measurement is performed in transmission mode. The SpO2 sensor consists of emitters which pass red and infrared light through peripheral sites such as a finger, toe or ear to a light-sensitive detector. For both wavelengths the change in absorption is continuously measured. In this way the pulsatile signal due to the arterial blood alone is extracted, excluding the offset due to absorption by venous blood, skin, bone, muscle and fat. This signal is used to determine the functional arterial oxygen saturation (SpO2) based on the fact that the amount of absorbed infrared light and red light is different for oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (Hb). The amount of red and infrared light received is compared and the percent of haemoglobin molecules bound with oxygen molecules calculated:

SpO2 =

HbO2 HbO2 + Hb

These measurement values are continuously displayed as a waveform (plethysmogram) and also used to determine the pulse rate. Note that the pulse oximeter equipment is calibrated to display the functional oxygen saturation. Certain physiological conditions, medical procedures, and external agents may interfere with the monitor’s ability to detect and display accurate SpO2 measurements (see chapter 9.2 for detailed information).

3

Product overview

3.1 Mainstream multigas monitor and Pulse oximeter – VM-2500-MG The VM-2500-MG is used together with an IRMA™ AX+ analyzer, an IRMA™ airway adapter and an application appropriate SpO2 sensor. Power is delivered via either the provided power supply, a rechargeable Li-Poly battery or 4 x AA batteries. Mainstream multigas monitoring is performed with the IRMA™ AX+ analyzer. This key technology sets new standards in multigas measurement and provides reliable, safe and easy anaesthetic agent monitoring. Key features of VM-2500-MG: • • • • • • • • • •

Innovative micro-optic technology Fast mainstream measurement without time delay Warm-up time 10 sec, full specifications within 60 sec Maintenance and calibration-free technology Adult/paediatric and infant IRMA™ airway adapters available Self-explanatory, ergonomic operating functions facilitate intuitive operation The colour information display, as well as the simple information structure, support quick decisions and a rapid user reaction in critical situations Leading-edge power management with standard alkaline batteries, Li-Poly batteries or medical external power supply (or combination) Wide range of high-quality SpO2 sensors available 2 years warranty

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3.2

Device components

3.2.1

IRMA™ AX+ analyzer

The IRMA™ AX+ analyzer is an ultra-compact measurement device for mainstream multigas measurement with the VM-2500-MG. As all necessary calibration constants are stored within each IRMA™ AX+ analyzer, the analyzer can be replaced without the need for recalibration. The analyzer has a rugged mechanical design providing reliable shock resistance.

Figure 3: IRMA™ AX+ analyzer with airway adapter

To perform gas measurements, the IRMA™ AX+ analyzer requires an airway adapter. The IRMA™ AX+ analyzer connects in place on top of the IRMA™ airway adapter. This airway adapter is, for example, inserted between the endotracheal tube and the Y-piece of the breathing circuit. Respiratory multigas measurements are obtained by continuously measuring the infrared light absorption, through optical XTPTM windows, in the gas flow through the adapter. 3.2.2

IRMA™ airway adapter

The IRMA™ airway adapter is designed as a single-patient-use disposable product and is available as: - IRMA™ airway adapter (adult/paediatric) for patients over 1 year of age or 10kg in weight. - IRMA™ airway adapter (infant) for patients up to 1 year of age or 10kg in weight. The IRMA™ airway adapter (infant) has specially designed connectors for minimizing the dead space and can be used on very small patients.

XTPTM window Figure 4: IRMA™ airway adapters: Infant (left) and Adult/Paediatric (right)

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As the airway adapter is positioned directly in the airway, its performance can be affected by water vapour, patient secretions or nebulised medications that can accumulate on the adapter’s windows. The water vapour can condense on the surface of the adapter windows in the format of small discrete water droplets. This condensation can affect light absorption through the windows, thus affecting the precision of the measurement. The XTP™ windows of the IRMA™ airway adapter therefore have special features that prevent a decrease in performance when vapour is present. Using the latest advances in material technology they are designed to provide a window minimizing the impact of water vapour on light transmission. For optimal results, the airway adapter shall not be placed between an endotracheal tube and an elbow, as this may allow patients secretions to block the adapter window. 3.3 SpO2 Sensors Viamed supplies a large variety of disposable and reusable SpO2 sensors for use with the VM-2500. Depending on the sensor type and model, their application ranges from adults to neonates, providing application specific features and design. The SC 6500 VM Sensor is typically used for adult applications and the W 6500 VM Sensor for infant and neonatal applications (see figure 5). Other sensors are available upon request.

Figure 5: SpO2 sensor SC 6500 VM (left) and W 6500 VM (right)

All sensors operate in transmission mode. The light source emits red and infrared light with wavelengths of 660nm and 905nm respectively at a typical radiant power of 3.5mW. The SpO2 sensor is applied to peripheral areas of the body such as finger tips and toes for adults, and paediatrics, and the foot or palms for infants and neonates.

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4

Exterior View, Controls and Connectors

Front view

No. Symbol

Side view

Feature/Button

Function

Arrow buttons (up/down)

Multifunction buttons used for: 1. Scrolling through menu items 2. Increasing/decreasing parameters 3. Shortcuts to volume/brightness control during monitoring

Display mode

Toggles between various display modes. Shortcut to return to display mode during menu mode.

1

2 3

Alarm silenced/reset

4

Top View

1. The audible alarm can be silenced for a maximum period of two minutes. Optical alarm remains activated. 2. To reset alarms press and hold the button for approx. 3 seconds.

Menu

Menu selection. Shortcut to return to the previous menu level during menu mode.

On/Off and ENTER button

1. To turn on the device: press and hold the button briefly. 2. To turn off the device: press and hold the button for approx. 3 seconds. 3. To confirms selection at the device: press and hold the button briefly while the device is switched on

5

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